Bortezomib With or Without Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Randomized phase II trial to compare the effectiveness of bortezomib with or without gemcitabine in treating patients who have metastatic pancreatic cancer. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with gemcitabine may kill more tumor cells.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bortezomib; Gemcitabine

Criteria

Inclusion Criteria:

• Histologically confirmed metastatic ductal or undifferentiated adenocarcinoma consistent with a pancreatic primary for which no standard curative measures exist

• No locally advanced disease only

• No islet cell, acinar cell, or cystadenocarcinomas

• Measurable disease

• At least one lesion whose longest diameter can be accurately measured as 2 cm or greater by conventional techniques OR 1 cm or greater by spiral CT scan

• A tumor lesion in a previously irradiated area allowed provided it is histologically confirmed disease with radiographic progression from a post-radiotherapy CT scan

• No CNS metastasis

• Performance status - ECOG 0-2

• At least 3 months

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9.0 g/dL

• Bilirubin no greater than 1.5 times upper limit of normal (ULN) (stents allowed)

• AST no greater than 5 times ULN

• PT and PTT no greater than ULN*

• Creatinine no greater than 1.5 times ULN

• No other prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No neuropathy greater than grade 1

• No underlying disease state associated with active bleeding

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after study participation

• More than 4 weeks since prior biologic therapy or immunotherapy

• No concurrent immunotherapy

• No concurrent colony-stimulating factors during the first course of the study

• No prior gemcitabine (even as a radiosensitizing agent)

• No prior chemotherapy

• Radiosensitizing agent as adjuvant therapy or for locally advanced disease allowed

• No other concurrent chemotherapy

• See Disease Characteristics

• More than 4 weeks since prior radiotherapy

• No prior radiotherapy to 25% or more of the bone marrow

• No concurrent radiotherapy

• No prior bortezomib